Nitrofurantoin

Product NDC
50268-625
11-digit product format
502680625
Labeler code
50268
Product ID
50268-625_d5def324-8b10-10e8-e053-2a95a90a89f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrofurantoin monohydrate/macrocrystals
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA207372
Marketing category
ANDA
Marketing start
2018-08-15
Marketing end
0000-00-00
Substance
NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-625-11EA - Each50268-625fcf10607-e182-47d2-a0d7-1051c0d581f212018-09-05
50268-625-15EA - Each50268-625e31f8248-adce-409a-bf48-f6e4266fb59212018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-625NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS) CAPSULE [AVPAK]3Legacy NDC20240110_736b2487-e83f-d172-e053-2a91aa0ab0cf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-625-155026806251550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-625-15) > 1 CAPSULE in 1 BLISTER PACK (50268-625-11) 50 blister pack2018-08-150000-00-00NoNoCurrent